Rosell R, Carles J, Abad A, Jimeno J M, Moreno I, Barnadas A, Ribelles N, Haboubi N
Medical Oncology Unit, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.
Invest New Drugs. 1992 Jul;10(2):123-8. doi: 10.1007/BF00873130.
Seventeen patients with small cell lung cancer entered a phase II trial testing the feasibility of adding high dose epirubicin (100-120 mg/m2, day 1) in combination with etoposide (60-80 mg/m2, days 1-5) and cisplatin (70 mg/m2, day 1) courses repeated every three weeks. Complete responders received thoracic (40 Gy) and prophylactic cranial (30 Gy) irradiation. Sixteen patients were evaluable for response and toxicity. Myelosuppression was the dose-limiting side effect. Neutropenic fever was observed in eight patients (53%) and stomatitis in six (40%). No patient had a greater than 14% decline in the cardiac ejection fraction. Strict adherence to the dose-schedule designed was impossible as doses were trimmed and delayed in 30% of instances. The overall objective response rate was 81% (95% confidence limits, 62% to 100%), in limited disease there were complete remissions in 57%. With a 16 months median follow-up, overall median survival was 13 months. This study was unable to prove the feasibility of epirubicin escalation when added to etoposide-cisplatin combination, hampering the dose-intensification Norton-Simon model test.
17例小细胞肺癌患者进入一项II期试验，该试验旨在测试添加高剂量表柔比星（100 - 120 mg/m²，第1天）联合依托泊苷（60 - 80 mg/m²，第1 - 5天）和顺铂（70 mg/m²，第1天），每三周重复疗程的可行性。完全缓解者接受胸部（40 Gy）和预防性颅脑（30 Gy）照射。16例患者可评估疗效和毒性。骨髓抑制是剂量限制性副作用。8例患者（53%）出现中性粒细胞减少性发热，6例（40%）出现口腔炎。没有患者的心脏射血分数下降超过14%。由于在30%的情况下剂量被调整和延迟，严格遵守设计的剂量方案是不可能的。总体客观缓解率为81%（95%置信区间，62%至100%），在局限性疾病中，完全缓解率为57%。中位随访16个月，总体中位生存期为13个月。这项研究未能证明在依托泊苷 - 顺铂联合方案中增加表柔比星剂量的可行性，阻碍了剂量强化诺顿 - 西蒙模型试验。
